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A clinical study to evaluate the safety and efficacy of a polypeptide protein immunobooster (IB-01) for enhancing immunity

A clinical study to evaluate the safety and efficacy of a polypeptide protein immunobooster (IB-01) for enhancing immunity

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082076
Enrollment
Unknown
Registered
2024-03-20
Start date
2024-01-08
Completion date
Unknown
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

compromised immunity

Interventions

Trial group:Polypeptide Protein Immunobooster (IB-01)

Sponsors

Shulan (Boao) Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) People aged between 20 and 65 (80% between 40 and 65); (2) Those who are weak and easy to get sick (meet 1 of them) : ? Colds =3 times per year; ?Bronchitis or pneumonia =2 times per year; ?Acute diarrhea (except lactose, wheat gum and other food intolerance) =3 times per year; ?Urinary tract infection =3 times per year; (3) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with immune dysfunction or serious blood system diseases, patients with advanced tumors and other serious underlying diseases, Such as systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, primary platelet purpura, autoimmune hemolytic anemia, Hashimoto's thyroiditis, primary myxedema, hyperthyroidism, ulcerative colitis and so on. (2) Allergic to multiple drugs or known components of the product of this study; (3) Women who are pregnant and planning for pregnancy in half a year, pregnant or lactating. (4) The chief complaint is unclear or has a history of epilepsy or central nervous system dysfunction, there are mental disorders can not cooperate; (5) Patients with severe diseases such as serious occupational diseases; (6) Patients with serious diseases of the heart, brain, liver, kidney and hematopoietic system;

Design outcomes

Primary

MeasureTime frame
Safety and tolerability;

Secondary

MeasureTime frame
Antigen-specific immune response;Detection of T cell subsets;T cell receptor sequencing;

Countries

China

Contacts

Public ContactZhongwei Wang

Shulan (Boao) Hospital

22896400@qq.com+86 136 1751 9212

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026