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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 29, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
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Registry record from ClinicalTrials.gov (NCT07905560). This is a study registration, not published results. Lead sponsor: Superluminal Medicines, Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 138 participants (ESTIMATED). Conditions: Healthy Participants. Interventions: DRUG: SUN-0864 or placebo; DRUG: SUN-0864 or placebo; DRUG: SUN-0864 or placebo; DRUG: SUN-0864 (Formulation 1) or SUN-0864 (Formulation 2); DRUG: Placebo. Primary outcome measures: Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 1) , Baseline up to Follow-Up (From Day -28 (Screening) to Day 37 (FUP visit); Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 2) , From Day -28 (Screening) to Day 60 (FUP visit); Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 3) , From Day -28 (Screening) to Day 119 (FUP visit); Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 4) , From Day -28 (Screening) to Day 37 (FUP visit); Cmax measurement of SUN-0864 in Part 4 , up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.; Tmax measurement of SUN-0864 in Part 4 , up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.; t1/2 measurement of SUN-0864 in Part 4 , up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.; AUClast measurement of SUN-0864 in Part 4 , up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.; AUCinf measurement of SUN-0864 in Part 4 , up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.; AUC24 measurement of SUN-0864 in Part 4 , up to 24 hours post-dose. Daily from Day 1 (Predose) to Day 3.. Brief 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.