assignment
Not Yet Recruiting

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

Trial statistics

location_city
5
research sites
public
1
country
medical_information
1
disease
person_search
5
investigators

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 PolandNot Yet Recruiting07 Jul 202619

Sites & Investigators

Conditions Studied in This Trial