Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

PharmaEssentia

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: P1101 (270 mcg); Drug: P1101 (48 mcg); Drug: P1101 (90 mcg); Drug: P1101 (225 mcg); Drug: Pegasys; Drug: P1101 (180 mcg); Drug: P1101 (24 mcg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05129644

A09-102

Details and patient eligibility

About

This was a single-center, double-blind, randomized, active control, single dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profiles of P1101 in 48 healthy volunteers.

Full description

The primary objectives were to determine the safety and tolerability of single ascending subcutaneous doses of P1101 and to determine the pharmacokinetics of P1101 in single ascending subcutaneous doses of P1101 in healthy male subjects.

The secondary objectives were to evaluate the occurrence of side effects in healthy subjects receiving either P1101 or PEGASYS; to compare the pharmacokinetic parameters for P1101 and PEGASYS; and to assess the effect of P1101 on the biomarkers 2',5' oligoadenylate synthetase and neopterin.

A total of 48 subjects were enrolled to receive subcutaneous injection of P1101 in the dose level of 24 , 48 , 90 , 180 , 225 , or 270 mcg or to receive subcutaneous injection of 180 mcg Pegasys.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

1. Be healthy males, non-smokers, ≥18 and ≤45 years of age;
2. Able to attend all scheduled visits and to comply with all study procedures.

Main Exclusion Criteria:

1. Clinically significant illness or surgery within 4 weeks prior to dosing;
2. Any clinically significant abnormality or abnormal laboratory test results found during screening;
3. Positive test for hepatitis B, hepatitis C, or HIV at screening;
4. Clinically significant vital sign abnormalities at screening;
5. History of significant alcohol or drug abuse within one year prior to the screening visit;
6. History of severe allergic or hypersensitivity reactions;
7. Use of an investigational drug or participation in an investigational drug trial within the last 4 weeks;
8. Any clinically significant history or presence of neurological, cardiovascular, pulmonary, hematological, immunologic, metabolic or other uncontrolled systemic disease;
9. Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety, and sleep disorders;
10. Body organ transplant and are taking immunosuppressants;
11. History of malignant disease;
12. History or presence of endocrine disorders;
13. History of coagulation disorders and blood dyscrasias;
14. Inability to comprehend the written consent form.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 7 patient groups

P1101 24 mcg

Experimental group

Description:

A total of 6 subjects received single dose of 24 mcg P1101

Treatment:

Drug: P1101 (24 mcg)

P1101 48 mcg

Experimental group

Description:

A total of 6 subjects received single dose of 48 mcg P1101

Treatment:

Drug: P1101 (48 mcg)

P1101 90 mcg

Experimental group

Description:

A total of 6 subjects received single dose of 90 mcg P1101

Treatment:

Drug: P1101 (90 mcg)

P1101 180 mcg

Experimental group

Description:

A total of 6 subjects received single dose of 180 mcg P1101

Treatment:

Drug: P1101 (180 mcg)

P1101 225 mcg

Experimental group

Description:

A total of 6 subjects received single dose of 225 mcg P1101

Treatment:

Drug: P1101 (225 mcg)

P1101 270 mcg

Experimental group

Description:

A total of 6 subjects received single dose of 270 mcg P1101

Treatment:

Drug: P1101 (270 mcg)

Pegasys 180 mcg

Active Comparator group

Description:

A total of 12 subjects received single dose of 180 mcg Pegasys

Treatment:

Drug: Pegasys