Health TrialsbyHealthPanel

A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorScholar Rock, Inc.

About this trial

A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female participants, ≥18 to ≤55 years of age, at the time of informed consent

BMI of ≥18 kg/m2 to ≤35 kg/m2 (inclusive) at screening

Disqualifiers

Previous treatment with SRK-439 or apitegromab, or with other anti-myostatin therapies, including ACTR antagonists.

History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening.

Current or prior use of anabolic steroids, growth hormones, or other substances with known effects on muscle.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Placebo

    Drug

    Matching placebo to SRK-439, subcutaneous administration

  • SRK-439

    Drug

    Single ascending dose, subcutaneous administration

  • SRK-439

    Drug

    Multiple ascending dose, subcutaneous administration

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Part AExperimental treatment 2 interventions
Group B: Part BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scholar Rock, Inc.

Lead sponsor

Source ClinicalTrials.gov
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