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New drug SRK-439 tested for safety in healthy adults

NCT ID NCT07444294

Knowledge-focused Sponsor: Scholar Rock, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 1 trial is testing the safety and tolerability of a new drug called SRK-439 in 76 healthy adults aged 18 to 55. Participants receive either a single or multiple doses of the drug or a placebo by injection. The study measures side effects, lab tests, and how the drug moves through the body. It is an early step to see if the drug is safe enough for future studies in patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SRK-439
What could go wrong
This is a very early Phase 1 study in healthy people, so it won't show if the drug works for any disease. The main goal is safety, not treatment.
Why investors are watching

Scholar Rock is testing SRK-439, an experimental drug, in a phase 1 trial with 76 healthy adults. The study checks the drug's safety, how the body processes it, and its effects at single and repeated doses. For a micro-cap company, this early readout is a key test of whether the drug is safe enough to move forward.

If it works: If the trial shows SRK-439 is safe and well-tolerated, Scholar Rock can advance the drug to later-stage studies. That progress could validate the company's research pipeline and support its value as a drug developer.

If it fails: Phase 1 trials often fail because the drug proves unsafe or causes unacceptable side effects. A negative result or a delay in the study could set back Scholar Rock's development plans and hurt investor confidence.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Male or female participants, ≥18 to ≤55 years of age, at the time of informed consent 2. BMI of ≥18 kg/m2 to ≤35 kg/m2 (inclusive) at screening Exclusion Criteria: 1. Previous treatment with SRK-439 or apitegromab, or with other anti-myostatin therapies, including ACTR antagonists. 2. History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening. 3. Current or prior use of anabolic steroids, growth hormones, or other substances with known effects on muscle. 4. Use of therapies with potentially significant muscle effects (eg, insulin-like growth factor, systemic beta-agonist, neurotoxins, or muscle relaxants or muscle-enhancing supplements) in any form within 3 months prior to screening or during the study. 5. Any history of exposure to a mAb or Fc domain-bearing recombinant protein within 5 years prior to screening with any prior history of hypersensitivity reactions from exposure 6. Treatment with other investigational drugs or devices in a clinical study or exposure to a biologic therapeutic within 3 months or 5 half-lives, whichever is longer, prior to screening.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Medpace CPU

    RECRUITING

    Cincinnati, Ohio, 45227, United States

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