A Phase 1 Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HuL001 in Healthy Volunteers and Multiple Sclerosis Subjects

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HuniLife Biotechnology, Inc.
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

Subjects who meet the following criteria will be eligible to participate in the study:

1. Aged between 18 and 55 years of age inclusive, at the time of signing the informed consent.

2. Female subjects and male subjects with female partners of child-bearing potential must agree to use adequate contraception (2 forms of birth control, one of which must be a barrier method). This criterion must be followed from the time of the first dose of treatment.

3. Able to understand, sign the written informed consent form, and follow the study procedures.

4. With no clinically significant abnormalities in vital signs, 12- lead ECG, and clinical laboratory assessments at screening as judged by the Investigator

5. Alanine aminotransferase (ALT), alkaline phosphatase (ALP), and bilirubin ≤ 1.5x upper limit of normal (ULN) (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).

6. Corrected QT interval using Fridericia's (QTcF) < 450 milliseconds (msec).

7. Body weight ≥ 50 kilogram (kg), < 75 kg and body mass MS Subjects only

8. Must have a confirmed diagnosis of relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) according to 2010 revisions to McDonald Criteria.

9. Have at least one of the following:

• At least 1 documented relapse within 1 year before screening, or

• Two documented relapses within the past 2 years before screening, or

• A new gadolinium (Gd)-enhancing lesion on magnetic resonance imaging (MRI) T1-weighted imaging within

1 year before screening, or

• A new T2 lesion on MRI within 1 year before screening. The subject must have 10 or less, Gd-enhancing lesions per T1-weighted MRI at screening as assessed by a central reader.

10. Expanded Disability Status Scale (EDSS) score between 0.0 and 6.0 at screening.

Exclusion Criteria:

Subjects presenting with any of the following criteria will be excluded from participating in the study:

1. A positive test for Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen, or Hepatitis C antibody result within 3 months of screening.

2. A positive pre-study drug or alcohol screen, or have a history of drug or alcohol abuse.

3. Female subjects who are breastfeeding, pregnant, or planning to become pregnant during the study period.

4. The Investigator considers that the subject is not in the condition to participate in this study.

5. Evidence or history of clinically significant (as judged by the Investigator) hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunologic, metabolic, urologic, dermatologic, neurologic (other than MS for MS subjects) or allergic diseases, or other significant clinical findings within 3 months prior to screening.

6. Abnormal baseline blood tests exceeding any of the limits defined below:

• ALT or aspartate transaminase (AST) > 1.5x ULN, ALP and bilirubin > 1.5x ULN (isolated bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)

• Total white blood cell count < 2,500/mm3; subjects with lymphocyte count less than the Lower Limit of Normal (LLN) may be included at the Investigator's discretion; platelet count < 95,000/mm3

• Creatinine > 2x ULN, calculated creatinine clearance < 60 mL/min (per Cockcroft & Gault)

• International Normalized Ratio (INR) larger than upper limit of the normal reference range (0.9 - 1.3).

7. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

8. Has participated in a clinical trial and has received an investigational product (IP) within 60 days prior to screening.

9. Unable to refrain from the use of prescription or nonprescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to screening, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety.

10. Previous history of anaphylaxis and severe allergic reaction, generation of neutralizing antibodies, or hypersensitivity to albumin or a protein-based therapeutic, including natalizumab (Tysabri) or any other monoclonal antibody.

11. Had blood donation within 60 days or had blood donation over 250 mL within 90 days prior to screening, or cannot commit to stopping blood donation during the study period.

12. Receipt of live vaccination within 1 month of screening (including flu vaccination) or plan to receive live vaccination during the study.

13. Previous exposure to any chimeric, humanized, or human monoclonal antibody, whether licensed or investigational (for healthy subjects only).

14. Have significant active infection (acute or chronic) within 28 days prior to screening. MS Subjects only

15. Subjects with primary progressive MS (PPMS).

16. Treatment with methylprednisolone or any other systemic steroid, for a relapse or otherwise, within 30 days of dosing.

17. Treatment with disease modifying therapies for RRMS or SPMS within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.

18. History of intolerance to paracetamol, ibuprofen, naproxen, or other non-steroidal anti-inflammatory agents.