ACE-031: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข2 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: ACE-031 protein solutions should be stored at 2-8 degrees Celsius (refrigerated). Protect from freezing and agitation. Protein solutions are sensitive to repeated freeze-thaw cycles which can cause aggregation and loss of activity.
Protocol Quick-Reference
Muscle growth and myostatin inhibition (discontinued investigational compound)
Dosing
Amount
1-3 mg/kg
Frequency
Every 2 weeks
Duration
12 weeks (based on Phase 2 DMD protocol; trial was terminated early)
Administration
Route
SCSchedule
Every 2 weeks
Timing
No specific time of day required; allow solution to reach room temperature before injection
โ Rotate injection sites
Cycle
Duration
12 weeks (based on Phase 2 DMD protocol; trial was terminated early)
Repeatable
Yes
Preparation & Storage
Storage: ACE-031 protein solutions should be stored at 2-8 degrees Celsius (refrigerated). Protect from freezing and agitation. Protein solutions are sensitive to repeated freeze-thaw cycles which can cause aggregation and loss of activity.
โ๏ธ Suggested Bloodwork (6 tests)
CBC with differential
When: Baseline
Why: Baseline blood cell counts
CMP (Comprehensive Metabolic Panel)
When: Baseline
Why: Liver and kidney function baseline
DEXA scan
When: Baseline
Why: Baseline lean body mass and fat mass measurement
Bone-specific alkaline phosphatase
When: Baseline
Why: Baseline bone formation marker
Coagulation panel (PT/INR, aPTT)
When: Baseline
Why: Baseline vascular/bleeding risk given epistaxis concern
DEXA scan
When: 12 weeks
Why: Assess lean mass and fat mass changes
๐ก Key Considerations
- โContraindication: Avoid in patients with bleeding disorders, vascular malformations, or hereditary hemorrhagic telangiectasia; discontinued due to vascular safety signals
Unlock dosing protocols
Free access to research-backed dosing information for all peptides.
150+ peptide profiles ยท 30+ comparisons ยท 18 research tools
| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Phase 1 single ascending dose (healthy volunteers) | 0.02 to 3.0 mg/kg subcutaneous injection | Single dose | Single administration with follow-up monitoring | Dose-dependent lean body mass increases observed at 1 and 3 mg/kg; highest dose (3 mg/kg) produced approximately 1 kg lean mass increase |
| Phase 2 DMD study (discontinued) | 1.0 to 2.5 mg/kg subcutaneous injection | Every 2 weeks | Planned 12-week course; terminated early due to safety concerns | Study terminated by DSMB due to vascular adverse events (epistaxis, telangiectasias); dose escalation was not completed |
Unlock full dosage protocols
Free access to complete dosing tables and protocol details.
150+ peptide profiles ยท 30+ comparisons ยท 18 research tools
๐Reconstitution Instructions
ACE-031 was supplied as a sterile solution for subcutaneous injection in clinical trials. As a discontinued investigational compound, no commercial formulation exists. Research-grade material requires verification of protein integrity, sterility, and endotoxin content before use.
Recommended Injection Sites
- โSubcutaneous (abdomen)
- โSubcutaneous (thigh)
๐งStorage Requirements
ACE-031 protein solutions should be stored at 2-8 degrees Celsius (refrigerated). Protect from freezing and agitation. Protein solutions are sensitive to repeated freeze-thaw cycles which can cause aggregation and loss of activity.
Community Dosing Protocols
Compare these clinical doses with what 15+ community members report using.
Based on 15+ community reports
View community protocolsResearch Tools
Before You Begin
Review safety warnings and contraindications before starting any protocol.
Dosing Disclaimer#
ACE-031 is a discontinued investigational compound that has never been approved for clinical use. All dosing information below is derived from published clinical trial protocols and is provided for educational and research reference purposes only. ACE-031 should not be used outside of properly designed and regulated clinical research.
Clinical Trial Dosing Protocols#
Phase 1 Study -- Single Ascending Doses#
The Phase 1 study evaluated single subcutaneous doses of ACE-031 in healthy postmenopausal women using a dose-escalation design.
| Dose Cohort | Dose (mg/kg) | Route | Observations |
|---|---|---|---|
| 1 | 0.02 | SC | Well tolerated; minimal pharmacodynamic effect |
| 2 | 0.05 | SC | Well tolerated; minimal effect |
| 3 | 0.1 | SC | Well tolerated; trend toward lean mass increase |
| 4 | 0.3 | SC | Well tolerated; measurable lean mass effect |
| 5 | 1.0 | SC | Significant lean mass increase observed |
| 6 | 3.0 | SC | Maximum lean mass increase (~1 kg); well tolerated with single dose |
Key pharmacodynamic findings from the Phase 1 study included dose-dependent increases in lean body mass measured by DEXA scan, with the most pronounced effects at 1.0 and 3.0 mg/kg. At the 3 mg/kg dose, mean lean body mass increased by approximately 1.0 kg compared to placebo within 29 days after a single injection. Fat mass showed trends toward reduction at the highest dose levels. Bone formation biomarkers (bone-specific alkaline phosphatase) increased at higher doses, suggesting anabolic bone effects.
These single-dose results established the proof of concept for ACE-031's biological activity and informed the dose selection for the Phase 2 study.
Phase 2 Study -- DMD Boys#
The Phase 2 study was designed as a randomized, double-blind, placebo-controlled trial in boys aged 4 and older with DMD.
| Parameter | Protocol |
|---|---|
| Starting dose | 1.0 mg/kg |
| Dose escalation | Up to 2.5 mg/kg |
| Route | Subcutaneous injection |
| Frequency | Every 2 weeks |
| Planned duration | 12 weeks (24 weeks with extension) |
| Actual duration | Terminated early by DSMB |
| Population | Boys with DMD, age 4 and older |
The study was terminated before completion due to the emergence of vascular adverse events at doses in the 1.0-2.5 mg/kg range administered biweekly. The DSMB's decision to halt the trial prevented determination of the full dose-response relationship and the maximum tolerated dose.
Pharmacokinetic Considerations#
Dosing Rationale#
The every-2-week dosing schedule was selected based on the estimated half-life of the ActRIIB-Fc fusion protein of approximately 10-15 days. This dosing interval was designed to maintain continuous suppression of circulating myostatin and activin levels throughout the treatment period.
Dose-Response Relationship#
The Phase 1 data demonstrated a clear dose-response relationship for lean body mass effects. The threshold dose for detectable lean mass changes appeared to be in the 0.3-1.0 mg/kg range. The 3.0 mg/kg dose produced the largest effects but was evaluated only as a single dose. Whether repeated dosing at this level would have produced proportionally greater lean mass gains or would have reached a plateau is unknown. The relationship between dose, lean mass changes, and vascular toxicity risk is important: it is not known whether there exists a therapeutic window where muscle effects are achieved without unacceptable vascular risk.
Administration#
Subcutaneous Injection#
ACE-031 was administered by subcutaneous injection in clinical trials. The relatively large volume required for body-weight-based dosing of a protein solution may necessitate multiple injection sites for higher doses.
Administration considerations:
- Calculate dose based on body weight (mg/kg)
- Determine injection volume based on the protein concentration of the formulation
- For volumes exceeding 1.5-2 mL, divide across multiple injection sites
- Rotate injection sites with each administration
- Monitor injection sites for local reactions
Injection Sites#
The abdomen (avoiding the umbilical region) and anterior thigh were the primary subcutaneous injection sites used in clinical trials. Sites should be rotated with each biweekly administration to minimize local tissue reactions and ensure consistent absorption.
Storage and Handling#
As a recombinant protein, ACE-031 requires careful handling to maintain structural integrity and biological activity. Store at 2-8 degrees Celsius (standard refrigerator temperature) in the original container. Do not freeze, as ice crystal formation can denature the protein and promote aggregation. Do not shake or agitate, as mechanical stress can cause protein unfolding at air-liquid interfaces. Protect from light. Allow the product to equilibrate to room temperature before injection. Inspect visually before use; do not use if solution is cloudy, discolored, or contains visible particles.
Monitoring#
In clinical trials, monitoring parameters included lean body mass and fat mass by DEXA scan, bone mineral density and bone biomarkers, serum myostatin and activin levels (pharmacodynamic markers), physical examination for vascular abnormalities (telangiectasias), monitoring for epistaxis and mucosal bleeding, muscle strength testing (in DMD study), and standard safety laboratory assessments.
Related Reading#
Subscribe to see vendor options
Free access to verified vendor scores, pricing, and suppliers.
150+ peptide profiles ยท 30+ comparisons ยท 18 research tools
Protocol updates
Get notified when we update dosing protocols or publish related comparisons.
Frequently Asked Questions About ACE-031
Explore Further
Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.