This is Comparative Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, Tolerability of Bmab 1200 -Autoinjector (AI) After Single Subcutaneous Injection (45 mg) in Comparison With Bmab 1200 -Prefilled Syringe (PFS).

NCT06738277 | Completed Phase 1

• 1 other identifier: BIO-USTEKI-104
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab 1200 -prefilled syringe (PFS).

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum observed concentration (Cmax) of drug Bmab 1200

  Week 16

• AUCo-∞

  Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf)

  Week 16

Secondary Outcomes (7)

• AUCo-t

  Week 16

• Tmax

  Week 16

• AUC_%Extrap_obs

  Week 16

• ƛz

  Week 16

• Vd

  Week 16

Study Arms (2)

Bmab 1200 AI (Biosimilar Ustekinumab)

EXPERIMENTAL

Drug: Bmab 1200 (Biosimilar Ustekinumab)

Bmab 1200 PFS (Biosimilar Ustekinumab)

ACTIVE COMPARATOR

Drug: Bmab 1200 (Biosimilar Ustekinumab)

Interventions

Bmab 1200 (Biosimilar Ustekinumab) DRUG

Dosage Form: injection, Strength(s): 45 mg/ 0.5 mL Route of Administration: Subcutaneous Frequency and Dose: 45 mg, single dose

Bmab 1200 AI (Biosimilar Ustekinumab); Bmab 1200 PFS (Biosimilar Ustekinumab)

Eligibility Criteria

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

You may qualify if:

• a.Non-smokers, healthy, adult, human volunteers between 18 to 55 years of age (both inclusive).
• b.Having BMI between 18.5 to 28.0 m2 and having a body weight between 60 kg and 90 kg (both inclusive for both parameters).
• c.Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
• d.Able to understand and comply with the study procedures, in the opinion of the investigator.
• e.Able to give voluntary written informed consent for participation in the study.
• f.Subjects should not receive a BCG vaccine within 1 year before dosing and agree to not take it during the study and at least 1 year after dosing.
• g.Subjects will agree not to receive live vaccination during the study. h.Subject will agree not to donate blood/ plasma/ platelets during the study and at least 3 months after the end of study.
• i.For male subjects i.Subjects agree to use effective contraception (e.g. Double barrier method) and refrain from donation of sperm from check-in until 90 days after the end of study.
• j.In case of female subjects: i.Surgically sterilized at least 6 months prior to study participation Or If subject is of child-bearing potential, is willing to use a suitable and effective double barrier contraceptive method or intrauterine device during the study and till 4 months after the end of study.
• Or Post-menopausal women. And ii.Serum pregnancy test must be negative. iii.Subjects will agree to refrain from donation of ova from check-in until 90 days after the end of study.

You may not qualify if:

• a. Known hypersensitivity or idiosyncratic reaction to ustekinumab or any excipients or any related drug or any substance (specifically any biologic product or the constituents of Bmab 1200).
• b. Known hypersensitivity to host cell \[ murine myeloma cell or Chinese hamster ovary cells\] derived proteins, latex), food, or other substance.
• c. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
• d. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes.
• e. Use or intend to use any prescription medications/products or other acceptable concomitant Medications within 30 days prior to dosing or slow-release medications/products considered to still be active within 14 days prior to check-in.
• f. Use or intend to use any nonprescription medications/ products, including vitamins, minerals, and phytotherapeutic/ herbal/ plant-derived preparations within 7 days prior to check-in.
• g. Use of any vaccine from 4 weeks prior to screening.
• h. The QTc interval more than 450 ms for male and more than 460 ms for female at the time of screening.
• i. Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs induced urticaria.
• j. A recent history of harmful use of alcohol (less than 2 years), or consumption of alcohol or alcoholic products within 48 hours prior to receiving study drug.
• k. Smokers, or who have smoked within the last six months prior to the start of the study.
• l. The presence of clinically significant abnormal laboratory values during screening.
• m. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
• n. History or presence of seizure or psychiatric disorders.
• o. A history of difficulty with donating blood.

Sponsors & Collaborators

• Biocon Biologics UK Ltd: lead

Study Sites (1)

Lambda Therapeutic Research Ltd

Ahmedabad, 382481, India

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: January 9, 2025
• Primary Completion: July 12, 2025
• Study Completion: July 12, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

IN (1)