Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)

ImmuneMed

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo (subcutaneous, single dose); Drug: Placebo (intravenous, multiple dose); Drug: Placebo (intravenous, single dose); Drug: hzVSF-v13 (subcutaneous, single dose); Drug: hzVSF-v13 (intravenous, single dose); Drug: hzVSF-v13 (intravenous, multiple dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04817202

hzVSF_v13-0002

Details and patient eligibility

About

Assessment of the safety, tolerability and pharmacokinetics (PK) characterization of hzVSF-v13 with single and multiple doses (intravenous and subcutaneous) compared to placebo in healthy subjects.

Full description

A phase I, double-blind, placebo-controlled, single and multiple dose

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females (of either childbearing or non-childbearing potential), of any race, between 18 and 60 years of age, inclusive on day of screening.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive on day of screening.

Exclusion criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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72 participants in 12 patient groups, including a placebo group

Group A1 (hzVSF-v13 50mg, intravenous, single dose)

Experimental group

Description:

Single administration (intravenous) of 50mg hzVSF-v13 on Day 1.

Treatment:

Drug: hzVSF-v13 (intravenous, single dose)

Group A2 (hzVSF-v13 100mg, intravenous, single dose)

Experimental group

Description:

Single administration (intravenous) of 100mg hzVSF-v13 on Day 1.

Treatment:

Drug: hzVSF-v13 (intravenous, single dose)

Group A3 (hzVSF-v13 200mg, intravenous, single dose)

Experimental group

Description:

Single administration (intravenous) of 200mg hzVSF-v13 on Day 1.

Treatment:

Drug: hzVSF-v13 (intravenous, single dose)

Group A4 (hzVSF-v13 400mg, intravenous, single dose)

Experimental group

Description:

Single administration (intravenous) of 400mg hzVSF-v13 on Day 1.

Treatment:

Drug: hzVSF-v13 (intravenous, single dose)

Group A5 (hzVSF-v13 800mg, intravenous, single dose)

Experimental group

Description:

Single administration (intravenous) of 800mg hzVSF-v13 on Day 1.

Treatment:

Drug: hzVSF-v13 (intravenous, single dose)

Group A6 (hzVSF-v13 1200mg, intravenous, single dose)

Experimental group

Description:

Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1.

Treatment:

Drug: hzVSF-v13 (intravenous, single dose)

Group A7 (hzVSF-v13 100mg, subcutaneous, single dose)

Experimental group

Description:

Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1.

Treatment:

Drug: hzVSF-v13 (subcutaneous, single dose)

Group B1 (hzVSF-v13 100mg, intravenous, multiple dose)

Experimental group

Description:

Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.

Treatment:

Drug: hzVSF-v13 (intravenous, multiple dose)

Group B2 (hzVSF-v13 400mg, intravenous, multiple dose)

Experimental group

Description:

Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.

Treatment:

Drug: hzVSF-v13 (intravenous, multiple dose)

Placebo (intravenous, single dose)

Placebo Comparator group

Description:

Single administration (intravenous) of placebo on Day 1.

Treatment:

Drug: Placebo (intravenous, single dose)

Placebo (subcutaneous, single dose)

Placebo Comparator group

Description:

Single administration (subcutaneous) of placebo on Day 1.

Treatment:

Drug: Placebo (subcutaneous, single dose)

Placebo (intravenous, multiple dose)

Placebo Comparator group

Description:

Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57.

Treatment:

Drug: Placebo (intravenous, multiple dose)