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A Clinical Study on the Safety and Tolerability of PL54 Injection in Adult Patients With Phenylketonuria (PKU)

NCT07672756 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-07-01

No results posted yet for this study

Summary

The primary objective of this clinical trial is to evaluate the safety and tolerability of single and multiple administrations of PL54 in patients aged 18-55 years. The key questions it aims to answer include:

How safe and tolerable is PL54 in PKU patients following single and multiple administrations?

Researchers will compare the safety and tolerability profiles between single and multiple dosing regimens to assess PL54.

Participants will be required to:

Phase Ia (Single Administration):

Receive a single subcutaneous injection of PL54 based on body weight. Undergo a 28-day observation period post-injection. Visit the clinic for assessments on: D1 (administration day), D2, D7, D8, D10, D15, D22, and D29.

Phase Ib (Multiple Administrations):

Receive subcutaneous injections of PL54 every 7 days (4 doses total) based on body weight. Undergo a 35-day observation period after the last injection. Visit the clinic for assessments on: D1 (first administration), D3, D8, D15, D21, D22, D29, D36, D43, and D57

Data to be recorded include:

Incidence, severity, seriousness, relationship to PL54 treatment, duration, and outcome of adverse events (AEs).

Change from baseline in blood phenylalanine (Phe) concentration.

Conditions

  • Phenylketonuria (PKU)

Interventions

BIOLOGICAL

PL54

Phase Ia: Single, subcutaneous injection administration. Dose escalation will start from the initial dose of 0.01 mg/kg and proceed sequentially to higher doses. Phase Ib: Administration via subcutaneous injection. Dosing frequency: once weekly. Dose escalation will start from the initial dose of 0.04 mg/kg and proceed sequentially to higher doses.

Sponsors & Collaborators

  • Chongqing Peg-Bio Biopharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-20
Primary Completion
2027-06-01
Completion
2027-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07672756 on ClinicalTrials.gov