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A Phase 2, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous Infusions of AZD9773 in Japanese Patients With Severe Sepsis and/or Septic Shock

A Phase 2, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous Infusions of AZD9773 in Japanese Patients With Severe Sepsis and/or Septic Shock

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221164
Enrollment
Unknown
Registered
2010-07-23
Start date
2010-07-23
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Severe Sepsis, Septic Shock

Interventions

investigational material(s) Generic name etc : AZD9773 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigatio
doses to be given every 12 hours over a period of 5 days Generic name etc : AZD9773 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Ad
doses to be given every 12 hours over a period of 5 days control material(s) Generic name etc : a saline solution INN of investigational material : Therapeutic category code : --- Other Dosage and A

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Japanese adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics. - At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells [WBC]) - Cardiovascular or respiratory dysfunction.

Exclusion criteria

Exclusion criteria: - Immunocompromising comorbidities or concomitant medications: 1. Advanced human immunodeficiency virus (HIV) infection (CD4 50/mm3 or less). 2. Haemopoietic or lymphoreticular malignancies not in remission. 3. Receiving radiation therapy or chemotherapy. 4. Any organ or bone marrow transplant within the past 24 weeks. 5. Absolute neutrophil count 30% of body surface area in the past 5 days. -Medication and allergy disqualifications. 1. Treatment with anti-TNF agents within the last 8 weeks. 2. Previously received ovine derived products (CroFab, DigiFab). 3. Sheep product allergy or allergy to papain, chymopapain.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026