Clinical Research Directory

A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.

Sponsor: Superluminal Medicines, Inc.

Summary

This Phase 1, first-in-human study will evaluate the safety and tolerability of SUN-0864, how the body processes SUN-0864, and how SUN-0864 affects the body in healthy adults and otherwise healthy adults who are overweight or obese. The study includes four parts: Part 1, a single ascending dose (SAD) assessment in healthy adults; Part 2, a 28-day multiple ascending dose (MAD) assessment in overweight or obese adults; Part 3, a 12-week multiple-dose assessment in overweight or obese adults; and Part 4, an assessment comparing two formulations and evaluating the effect of food on SUN-0864 in healthy adults. Approximately 128 to 138 subjects will be randomized into this study. Dose escalation and selection of dose levels for later study parts will be guided by review of safety, tolerability, and available study data by a Safety Review Committee.

Official title: A First-In-Human, Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Limited Duration Treatment, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SUN-0864 in Healthy Adult Participants and Participants Who Are Overweight and/or Obese, Otherwise Healthy

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