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Phase 1Not yet recruiting

A Phase 1 Study of VELA-101 in Adult Participants

A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VELA-101 in Adult Participants

Sponsor
Ursa Medicines (Industry)
Enrolment
60 planned
Conditions
Healthy Participants; Hyperlipidemia
Interventions
VELA-101; Placebo
Ages
adults, older adults
Registry
NCT07864311

Full record on ClinicalTrials.gov

From the registry

This is a first-in-human (FIH), multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VELA-101, following single-ascending doses via subcutaneous (SC) administration.

Primary outcomes

  • To evaluate the safety and tolerability of single ascending doses of VELA-101, as assessed by the incidence and severity of treatment-emergent adverse events and vital signs, electrocardiogram, and and clinical laboratory parameters

History

  1. Primary completion expected

  2. Expected to start

  3. Last registry update

  4. Registered