A Study of PN20 in Healthy Adult Volunteers

NCT06523088 | Completed Phase 1

• 1 other identifier: 2021-PK-PN20-32
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are:

• Is PN20 safe in adult? Researchers will compare PN20 to a placebo (a look-alike substance that contains no drug) to see if PN20 is safe. Participants will
• Receive a single dose injection of PN20 or placebo according to weight,
• Stay in hospital for assessment.

Conditions

Chemotherapy-induced Thrombocytopenia; Immune Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

• Treatment-related Adverse Events

  Number of participants with treatment-related adverse events during the study will be collected and the percentage of AE of different grades as assessed by CTCAE v5.0 will be assessed.

  up to 15 days

Study Arms (2)

PN20 group

EXPERIMENTAL

subcutaneous injections, a single dose

Drug: PN20

Placebo group

PLACEBO COMPARATOR

subcutaneous injections, a single dose

Drug: Placebo

Interventions

PN20 DRUG

Six dose levels of PN20 will be evaluated

Also known as: thrombopoietin receptor agonist

PN20 group

Placebo DRUG

Placebo of PN20

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects aged 18 to 50 years;
• Body mass index between 19.0-28.0 (inclusive), body mass index (BMI) = weight (kg)/height\^2 (m\^2);
• Female subjects of childbearing age with negative serum pregnancy test results;
• Platelet counts during the screening period and one day before enrollment are within the range of 100-300×10\^9/L;
• Eligible subjects of fertility must agree to use effective contraceptive measures or abstain from sex within 6 months after receiving the investigational drug;
• Be able to understand and comply with the requirements of the protocol and expected to complete the entire trial process;
• Voluntarily participate and sign the informed consent form.

You may not qualify if:

• Abnormal results of vital signs examination with clinical significance determined by the investigator;
• Positive test results for HIV-Ab, HCV-Ab, HBsAg, HBeAg, or treponema pallidum antibodies;
• Abnormal results of laboratory test (blood routine, urine routine, blood biochemistry, coagulation) with clinical significance determined by the investigator;
• Abnormal electrocardiogram with clinical significance or prolonged QT/QTc interval is, such as QTcB ≥ 430ms (male), or QTcB ≥ 450ms (female) (machine reading results); family history of QT prolongation;
• Positive drug abuse test or alcohol test ≥20mg/dL;
• Abnormal results of chest CT or COVID-19 screening (nucleic acid and C-reactive protein) with clinical significance determined by the investigator;
• Have taken any drugs (including prescription drugs, over-the-counter drugs and Chinese herbal medicines) within 4 weeks before enrollment, except for external drugs that are not absorbed by the body;
• Have used drugs known to cause significant damage to certain organs within 12 weeks before enrollment;
• Participated, enrolled and been administered in other clinical trials within 3 months before enrollment, or used this investigational drug or similar drugs;
• Received live attenuated vaccines within 28 days before administration of the trial drug and/or received inactivated vaccines within 7 days before administration, and/or plan to receive vaccines during the trial;
• Allergic constitution, or history of drug allergy, or history of allergy to the ingredients of this investigational drug;
• Have a history of major surgery or a history of blood donation ≥200 mL within 12 weeks before enrollment or who plan to donate blood during the study;
• Have a history of any serious clinical disease, including but not limited to diseases of the digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system (such as epilepsy, dementia, etc.), blood system, and immune system And those with a history of metabolic abnormalities, deep vein thrombosis, thrombocytopenia, thrombocythemia, platelet dysfunction, etc.;
• Smoke more than 5 cigarettes a day or have a history of alcohol abuse in the 6 months before enrollment, that is, drink more than 14 units of alcohol per week (1 unit = 12 ounces or 360mL of beer, 1.5 ounces or 45mL of hard liquor with 40% alcohol content, 5 ounces or 150mL of wine);
• Drink more than 1L of strong tea, coffee and/or caffeinated beverages every day;

Sponsors & Collaborators

• Chongqing Peg-Bio Biopharm Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangshu, 215006, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Liyan Miao

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: It is an open-label study at first dose level, and switched to double-blind study starting from the second dose level.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: June 16, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: March 13, 2025

Record last verified: 2024-07

Locations

CN (1)