A Phase 1 interventional study of Placebo and SRK-439 in Healthy, sponsored by Scholar Rock, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Scholar Rock, Inc. · Phase 1, Interventional, and Treatment
A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults
Scholar Rock, Inc. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be treated with a single dose of SRK-439 or matching placebo.
Drug: Placebo · Drug: SRK-439
Participants will be treated with multiple doses of SRK-439 or matching placebo.
Drug: Placebo · Drug: SRK-439
Matching placebo to SRK-439, subcutaneous administration
Single ascending dose, subcutaneous administration
Multiple ascending dose, subcutaneous administration
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
• Incidence of AEs
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
• Incidence of SAEs
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Changes from baseline in clinical safety laboratory tests (serum chemistry)
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Changes from baseline in clinical safety laboratory tests (hematology)
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Changes from baseline in clinical safety laboratory tests (urinalysis)
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Changes from baseline in clinical safety laboratory tests (coagulation assessments)
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Changes from baseline in vital signs (heart rate) measured in bpm
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Changes from baseline in vital signs (blood pressure) measured in mmHg
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Changes from baseline in vital signs (respiratory rate) measured in rpm
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Changes from baseline in vital signs (body temperature) measured in Celsius
Time frame: Up to 32 weeks
Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Changes from baseline in ECG measurements
Time frame: Up to 32 weeks
Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants
• Maximum observed serum concentration \[Cmax\]
Time frame: Up to 32 weeks
Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants
• Time to maximum observed concentration in serum \[Tmax\]
Time frame: Up to 32 weeks
Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants
• Area under the serum concentration-time curve \[AUC\]
Time frame: Up to 32 weeks
Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants
• Terminal elimination half-life in serum \[t1/2\]
Time frame: Up to 32 weeks
Evaluate the PD of single and multiple SRK-439 SC dose administration in healthy adult participants
Serum concentrations of total latent myostatin and changes over time
Time frame: Up to 32 weeks
Evaluate the immunogenicity of single and multiple SRK-439 SC dose administration in healthy adult participants
Incidence of ADAs against SRK-439 in serum
Time frame: Up to 32 weeks
Started Nov 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
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Scholar Rock, Inc.