An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)

An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) - RO7112689 phase I/II study (Part 1a conducted in NL)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43007

Enrollment

Registered

2016-09-15

Start date

2016-09-22

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

PNH

Interventions

The volunteer will receive a single dose of RO7112689 or placebo as an intravenous (iv) infusion of 1 hour or as a subcutaneous injection on Day 1. The placebo dose is an iv infusion or a subcutaneo

RO7112689

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male volunteers 21-55 yrs, inclusive BMI: 18-30 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
- Evaluate the safety and tolerability of single doses of RO7112689 in HVs.	—

Secondary

Measure	Time frame
- Characterize the pharmacodynamic (PD) effects of a single-dose of RO7112689 on complement activity and other related biomarkers. - Describe the single-dose pharmacokinetic (PK) profile of RO7112689. - Explore the PK/PD relationship of single-ascending doses of RO7112689 on complement activity and other related biomarkers. - Evaluate the immunogenicity of RO7112689 in healthy volunteers. - Assess the bioavailability of SC administration of RO7112689. - Assess ethnic sensitivities across Japanese and non-Japanese healthy volunteers.	—

Measure

Time frame

- Characterize the pharmacodynamic (PD) effects of a single-dose of RO7112689 on complement activity and other related biomarkers. - Describe the single-dose pharmacokinetic (PK) profile of RO7112689. - Explore the PK/PD relationship of single-ascending doses of RO7112689 on complement activity and other related biomarkers. - Evaluate the immunogenicity of RO7112689 in healthy volunteers. - Assess the bioavailability of SC administration of RO7112689. - Assess ethnic sensitivities across Japanese and non-Japanese healthy volunteers.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)