Phase 1 Single-Ascending Dose Study Assessing Safety, Tolerability, and Pharmacokinetics of PF-07832837 in Healthy Adults and Adults with Atopic Dermatitis
- Trial ID
- 2025-524150-34-00
- Protocol
- C4991001
- Sponsor
- Pfizer Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to assess the tolerability and pharmacokinetic profile of escalating doses of PF-07832837 in healthy volunteers and participants diagnosed with atopic dermatitis, thereby determining the dose range that can be administered safely.
Participants
The trial enrolled 23 participants diagnosed with Atopic Dermatitis. Both female and male individuals were included, encompassing the vulnerable population. Subjects were selected from patient groups aged according to the study’s age‑range codes 3 and 4, corresponding to pediatric and adolescent ages. All participants were otherwise generally healthy aside from the target condition. The enrollment criteria required a confirmed diagnosis of the disease; individuals with other significant dermatologic or systemic illnesses were excluded. Lifestyle factors such as diet or physical activity were not specified as selection criteria.
Plans and Procedures
A Phase 1 trial evaluates the tolerability and pharmacokinetics of the investigational agent PF-07832837 in healthy adults and subjects with atopic dermatitis. Participants first attend a screening visit to confirm eligibility, then receive study drug doses with scheduled follow‑up visits to monitor safety, adverse events, and drug exposure. The study ends with an end‑of‑study visit that includes final assessments. Involvement extends from the screening appointment through the final visit, covering the overall trial period estimated from July 2026 to January 2028. Early termination may occur if a participant withdraws consent, experiences a serious adverse event, or does not comply with protocol requirements.
Efficacy
Efficacy assessments for Atopic Dermatitis will be conducted in accordance with the predefined study protocol.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Poland | Not Yet Recruiting | 07 Jul 2026 | 19 |

