# A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects

> **NCT07126704** · PHASE1 · NOT_YET_RECRUITING · sponsor: **1ST Biotherapeutics, Inc.** · enrollment: 72 (estimated)

## Conditions studied

- Healthy

## Interventions

- **DRUG:** FB-101
- **DRUG:** Placebo for FB-101

## Key facts

- **NCT ID:** NCT07126704
- **Lead sponsor:** 1ST Biotherapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2025-11
- **Primary completion:** 2026-06
- **Final completion:** 2027-06
- **Target enrollment:** 72 (ESTIMATED)
- **Last updated:** 2025-08-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07126704

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07126704, "A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT07126704. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*