A Study of Injection HB0017 in Adult Healthy Volunteers

NCT04505033 | Completed Phase 1 FDA Drug

• 1 other identifier: HB0017-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

placebo by subcutaneous (SC) administration. Forty subjects (10 subjects per cohort for SC administration) will be randomized and assigned to up to 4 sequential doses cohorts of HB0017 (50 mg, 150 mg, 300 mg and 450 mg) or matching placebo. Each cohort of ten volunteers will be randomly assigned to receive either a single dose of HB0017 or matching placebo at a ratio of 4:1. Starting with the lowest dose, each of the subsequent doses will be administered only if the preceding dose was determined to be safe and well tolerated. The decision to escalate the next dose will be made jointly by the sponsor s medical expert and the investigator based upon review of 15-day blinded safety data prior to dosing each cohort.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Incidence, nature, relatedness, and severity of AEs.

  113Days.

Secondary Outcomes (3)

• AUC (Area Under Curve) after single dose

  1month

• T1/2 (Elimination Half-life) after single dose

  1month

• Cmax (Maximum Serum Concentration) after single dose

  1 month

Study Arms (8)

50 mg s.c

EXPERIMENTAL

Drug: HB0017

50 mg placebo

PLACEBO COMPARATOR

Drug: placebo

150 mg s.c.

EXPERIMENTAL

Drug: HB0017

150 mg placebo

PLACEBO COMPARATOR

Drug: placebo

300 mg s.c.

EXPERIMENTAL

Drug: HB0017

300 mg placebo

PLACEBO COMPARATOR

Drug: placebo

450 mg s.c.

EXPERIMENTAL

Drug: HB0017

450 mg placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

HB0017 DRUG

HB0017 at 100 mg/mL (1 mL/vial) in 2 mL glass vial with a rubber stopper. HB0017 will be administered in the abdominal area by a subcutaneous injection in the mornings. A maximum volume of 1 mL is injected per site.

Also known as: recombinant humanized IgG1 monoclonal antibody

150 mg s.c.; 300 mg s.c.; 450 mg s.c.; 50 mg s.c

placebo DRUG

A matching injection solution containing a specific volume of normal saline (0.9%, Sodium Chloride Injection USP) and no active substance will be prepared for the subjects who will be assigned to placebo according to the dose schedule.

Also known as: 0.9%, Sodium Chloride Injection USP

150 mg placebo; 300 mg placebo; 450 mg placebo; 50 mg placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet the following criteria to be eligible for study entry:
• Healthy male or female subjects age ≥ 18 and ≤ 55 years.
• Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use one of the following acceptable contraceptive method throughout the study and for 112 days after the study drug administration:
• Simultaneous use of intra-uterine contraceptive device without hormone release system placed at least 4 weeks prior to study drug administration, and condom for the male partner;
• Simultaneous use of diaphragm with intravaginally applied spermicide and male condom for the male partner, starting at least 21 days prior to study drug administration.
• Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner \[sterile female partners include post-menopausal women (absence of menses for 12 months prior to drug administration) or women who have had a tubal ligation, hysterectomy, or bilateral oophorectomy (at least 6 months prior to drug administration)\] must be willing to use one of the following acceptable contraceptive method throughout the study and for 112 days after the study drug administration:
• simultaneous use of condom, and for the female partner hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks);
• simultaneous use of male condom, and for the female partner, diaphragm with intravaginally applied spermicide;
• Body Mass Index (BMI) ≥ 18.5 and ≤ 30 kg/m².
• No clinically significant findings in the medical history and physical examination.
• No clinically significant laboratory values (including urinalysis), unless the investigator considers any abnormality to not be clinically significant.
• Normal ECG, blood pressure, respiratory rate, temperature and heart rate, unless the investigator considers any abnormality to be not clinically significant.
• Informed consent must be obtained in writing for all subjects enrolled into the study.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from study entry:
• History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease.
• Current or history of malignancy (subjects with squamous cell skin cancer maybe included based on investigator assessment.).
• Family history of premature Coronary Heart Disease (CHD).
• Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Exposure to any prescription medication 14 days prior to randomization, to herbal remedies or over-the counter medications 7 days prior to randomization.
• Participation in another research with any investigational product within 28 days or 5 half-lives of the drug, whichever is greater, before screening.
• Any medical history of asthma, allergic rhinitis or urticarial, or any other clinically significant allergy reaction including food allergy. Known allergy to biologics.
• Blood or plasma donation of more than 500 mL during the previous 2 months and/or more than 50 mL in the 2 weeks prior to screening.
• Had a vaccination with a live attenuated vaccine within 6 months prior to dosing.
• Subjects at risk for tuberculosis (TB), specifically subjects with:
• Current clinical, radiographic or laboratorial evidence of active TB.
• History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening.
• Positive QuantiFERON®-TB test with positive chest X-ray, indicating possible tuberculosis infection. Subjects with positive QuantiFERON®-TB test with documented completion of treatment for latent TB can be included into the study.
• Positive test for hepatitis B, hepatitis C, or HIV at screening.
• History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).

Sponsors & Collaborators

• Huabo Biopharm Co., Ltd.: lead

Study Sites (1)

Auckland Clinical Studies Ltd

Grafton, Auckland, 8963, New Zealand

Location

Related Publications (1)

• Jiang C, Du Y, Liu X, Wang J, Ge C, Xu J, Wang S, Li B, Zhu G, Zhang W, Qian Q, Ma C, Zhu X, Zhan Y, Yang Y. Safety, tolerability, pharmacokinetics and efficacy of HB0017, a humanized monoclonal antibody that targets interleukin-17A, in healthy participants and patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2023 Dec 20;190(1):28-36. doi: 10.1093/bjd/ljad315.

  PMID: 37669307 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: October 2, 2020
• Primary Completion: January 2, 2021
• Study Completion: February 1, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

NZ (1)